Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.

Pharmacokinetic Model Based on Population Physiology of Oral and Intranasal Formulations of Zolmitriptan in Healthy Volunteers

This is a phase I study to evaluate the PBPK of zolmitriptan intranasal versus oral administration.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Zolmitriptan intranasal.; Drug: Zolmitriptan oral.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • IMIM (Hospital del Mar Medical Research Institute)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female volunteers by physical examination, vital signs, ECG, and safety laboratory parameters and results must be within normal ranges or considered not clinically relevant by the investigator.
• Age ≥ 18 years and ≤ 55 years.
• Body mass index (BMI) ≥ 18 and ≤ 30.
• Able/willing to accept restrictions regarding diet, physical exercise, and consumption of alcohol and/or xanthine-containing items when outside the Clinical Research Unit (CRU)
• Able to read Spanish and adhere to study requirements.
• Informed consent signed before any procedure required by the study.

Exclusion Criteria:

• Smoking.
• History or clinically relevant diseases.
• Be under administrative or legal supervision.
• Pregnancy and breastfeeding.
• Positive blood or urine drug of abuse test or breathalyzer prior to study drug administration.
• Any history, disease, disorder, condition, anomaly or clinical finding that is relevant in the judgment of the investigator that may interfere with the study.
• Known hypersensitivity to any drug or excipient of the drug.
• Use of medications, inhibitors, any prescription or over-the-counter products, including herbs, homeopathy, vitamins, minerals, and nutritional supplements, before or during the study, that may interfere with the conduct and results of the study.
• Donation or transfusion of blood or plasma before, during or after study drug administration.
• History of inadequate venous access and/or experience of difficulty donating blood.
• Not being able/unwilling to accept restrictions regarding diet, physical exercise and consumption of alcohol and/or articles containing xanthine when outside the CRU.
• Subject included in a clinical study in the 3 months prior to the study drug administration.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zolmitriptan intranasal.	Drug: Zolmitriptan intranasal.; Zolmitriptan nasal spray is supplied in a single-use, ready-to-use spray unit. It is administered in one nostril. The full protocol will explain how to use it. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.
Experimental: Zolmitriptan oral.	Drug: Zolmitriptan oral.; Zolmitriptan 5 mg orally disintegrating tablet is to be taken without liquids. For oral administration, each tablet will be placed in the top of the tongue without any liquid and will disperse in a matter of seconds, then be swallowed with saliva. Following drug administration, study subjects will continue to fast for a minimum of 4h and snacks and standard meals may be served at scheduled times after drug administration (snack: +4h; lunch: +7h; snack: +10h). Liquid intake will not be allowed from 2h before to 2h after drug administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Zolmitriptan on Heart Rate (HR).	To assess the effects of Zolmitriptan on HR; only results at 24 hours will be reported.	Up to 24 hours.
Effects of Zolmitriptan on Systolic Blood Pressure (SBP).	To assess the effects of Zolmitriptan on SBP; only results at 24 hours will be reported.	Up to 24 hours.
Effects of Zolmitriptan Diastolic Blood Pressure (DBP)	To assess the effects of Zolmitriptan on DBP; only results at 24 hours will be reported.	Up to 24 hours
AUC(0-24h)	Area under the curve from 0 time to the last measurable concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.	up to 24 hours
Tmax	Time of maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations.	Blood samples were taken pre-dose and up to 24 hours after start of each Dose
Cmax	The mean maximum observed concentration (of oral and intranasal zolmitriptan), calculated from individual plasma PK concentrations	Blood samples were taken pre-dose and up to 24 hours after start of each Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects (AE)	AE was performed including number and percentage.	Up to 24 hours.

Other Outcome Measures

Outcome Measure	Time Frame
Adverse effects.	Up to 24 hours.

Collaborators and Investigators

• Sponsor: Parc de Salut Mar
• Collaborators: Food and Drug Administration (FDA)

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Protein Synthesis Inhibitors; Serotonin Agents; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; zolmitriptan
• Other Study ID Numbers: IMIMFCTL/ZOL_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No